IQ practical workbook
Develop an installation baseline, evidence row, discrepancy record and OQ handover recommendation.
Fictional V-201 oral-liquid vessel only. Do not enter confidential site or patient data. Answers are not stored or transmitted; print before closing.
IQ evidence template (CSV) · Installation findings template (CSV)
Activity 1 · What installation qualification establishes
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Classify: sensor serial matches schedule; alarm stops heating; batch blend is uniform. Explain the evidence boundary.
Model reasoning
The first is installation identity evidence. Alarm response needs a defined operational challenge. Blend uniformity needs a justified performance/process study; neither is proven by identity alone.
Activity 2 · Prepare the IQ baseline and protocol
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Write an IQ check for outlet valve identity with baseline, criterion, safe method and evidence fields.
Model reasoning
Name the controlled schedule and revision, required tag/model, visual method, actual observed identifiers, evidence reference, executor/date and discrepancy route. Confirm safe access; do not infer acceptance from an unapproved drawing.
Activity 3 · Conduct a physical installation walkdown
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Write a finding for a rear instrument blocked by a pipe rack. Separate observation, criterion and impact.
Model reasoning
Record the location and obstruction, cite the approved removal envelope/manufacturer instruction, identify maintenance implications, assign an action and specify reinspection. Do not invent a clearance value.
Activity 4 · Verify materials and component traceability
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Build a three-row contact-material register and describe how to handle a missing gasket traceability link.
Model reasoning
Include body, gasket and outlet component; record specification, installed identifier, evidence reference and status. Keep the gasket unresolved, obtain applicable evidence or authorized correction, and reassess any material change.
Activity 5 · Verify piping and utility interfaces
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
List separate evidence for a correctly installed utility connection and suitable delivered utility quality.
Model reasoning
Installation evidence includes route, isolation, labels and drawing comparison. Quality evidence follows the approved utility qualification and relevant point-of-use requirements. Cross-reference both; neither substitutes for the other.
Activity 6 · Review instruments and calibration evidence
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Calculate indication error for 40.4 °C versus 40.0 °C, then identify information needed beyond the arithmetic.
Model reasoning
Error is +0.4 °C, within the fictional ±0.5 °C magnitude limit. Confirm instrument identity, applicable method/range, uncertainty, decision rule and calibration status before concluding suitability.
Activity 7 · Assemble supplier and configuration records
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Prepare a handover index for instructions, configuration and supplier evidence, including one limitation.
Model reasoning
Index document identifier, revision, installed-model applicability, location and owner. Explain that a software-version record establishes identity only; define separate functional validation. Justify any supplier evidence reuse.
Activity 8 · Execute and record defensible observations
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Rewrite “all items OK” as an evidence-linked valve check, then explain an uninspected hidden connection. Identify where original records, photographs, printouts and raw electronic data will be retained, the responsible owner and the applicable retention schedule.
Model reasoning
Record actual tag/model, location, comparator revision and evidence reference with execution details. Mark the hidden connection not checked with reason and follow-up; do not call it not applicable just to complete the form. Identify the controlled original-data location, owner, retention schedule and integrity controls; do not invent a universal retention period.
Activity 9 · Investigate discrepancies and manage changes
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Draft a discrepancy entry for the wrong valve and identify what is required before closure or limited progression.
Model reasoning
Record expected/actual model and evidence, assess impact, use the controlled correction/change route, define reinspection and retain history. Any limited OQ progression needs an activity-specific no-significant-impact assessment and authorization.
Activity 10 · Report IQ and hand over to OQ
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Prepare a short IQ handover with scope, evidence references, open gasket finding, restrictions and proposed OQ decision.
Model reasoning
State the baseline and supported installation checks, retain the gasket gap, hold dependent wetted tests and request a documented decision for any separate activity. Include owners and evidence locations; 90% coverage does not authorize progression.
Capstone rubric
Give each dimension 0 (missing), 1 (partial) or 2 (supported): controlled baseline; criteria and actual observations; evidence traceability; discrepancy impact and verification; bounded handover recommendation. This 10-point self-review rubric is not a competency certification. Invented evidence or unsupported routine-use approval requires correction irrespective of the score.